The estimated absorbed radiation doses to an average (70 kg) patient from an intravenous dose of 100 μCi (3.7 megabecquerels) of GLOFIL® -125 are shown in Table 4. Calculations assume that there is 1% free iodide in the preparation and that the thyroid uptake of the iodine is 25%.
|Absorbed radiation doses for 100 µCi (3.7 megabecquerels)|
|2 hour bladder voiding interval||4.8 hour bladder voiding interval|
|Lower Large Intestine Wall||0.00065||0.0065||0.0012||0.012|
|Upper Large Intestine Wall||0.00040||0.0040||0.00044||0.0044|
|Urinary Bladder Wall||0.022||0.22||0.06||0.6|
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
No. 1000, GLOFIL® -125 is a clear, colorless, sterile, and nonpyrogenic solution available as a 4 mL vial. It is supplied in a concentration of approximately 1 mg/mL sodium iothalamate (range is 0.5–2.0 mg sodium iothalamate per mL), with a radioactivity concentration of 250 to 300 μCi/mL at the time of calibration. Benzyl alcohol 0.9%, is added as a preservative. Sodium bicarbonate and hydrochloric acid are added for pH adjustment. The calibration and expiration dates are shown on the label.
Refrigerate the product upon receipt at 2°C to 8°C.
Table 3 provides the required factors for the determination of activity per mL post calibration date for GLOFIL® -125 sterile solution.
To determine the dose volume, locate the decay factor (fraction remaining) which corresponds to the day that the dose is to be administered. The following equation is then utilized to determine the dose volume:
(activity of desired dose) /[(decay factor) x (amount of activity/mL on calibration day)] = dose volume (mL) (information on label)
- Sigman EM, Elwood CM, Reagan ME, Morris AM, Catanzaro A. The renal clearance of 131 I labeled sodium iothalamate in man. Invest Urol 1965; 2:432.
- Cohen ML, Smith FG Jr., Mindell RS, Vernier RL. A simple reliable method of measuring glomerular filtration rate using single low dose sodium iothalamate 131 I.Pediatrics 1969; 43:407.
- Maher FT, Nolan NG, Elveback LR. Comparisons of simultaneous clearances of 125 I-labeled sodium iothalamate (Glofil) and of Inulin. Mayo Clin Proc 1971; 46: 690-691.
- Skov PE. Glomerular filtration rate in patients with severe and very severe renal insufficiency. Acta Med Scand 1970; 187: 419-428.
Manufactured by Iso-Tex Diagnostics, Inc. for QOL Medical
Kirkland, WA 98033
Revised April 2006
iothalamate sodium, i-125 injection
|Labeler — QOL Medical|
Revised: 06/2007 QOL Medical
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